Laparoscopic surgical techniques have been developed in order to avoid large skin incisions associated with traditional surgery, using small incisions (of 5-12 mm) in which surgical instruments are inserted. These surgical instruments may be used to dissect and remove tissues and organs (specimens) which may be several centimeters in diameter. Such minimally invasive surgical techniques have been evolving for more than 100 years, since Georg Kelling performed the first experimental laparoscopy in 1901. (Litynski, G. Endoscopic surgery, the history, the pioneers. World J. Surg. 1999 August; 23(8):745-53). These minimally invasive laparoscopic surgeries result in less post-operative pain, quicker recovery and an improved cosmetic appearance for patients compared to traditional laparotomy. Currently, hybrid procedures combining flexible endoscopy and laparoscopy, such as intraoperative enteroscopy and laparoscopic-assisted endoscopic retrograde cholangiopancreatography, are performed in increasing numbers. (Ceppa, F., et al. Laparoscopic transgastric endoscopic retrograde endoscopy after Roux-en-Y gastric bypass. Surg. Obes. Relat. Dis. 3: 21-24 2007; Peters, M., et al. Laparoscopic transgastric endoscopic retrograde cholangiopancreatography for benign common bile duct structure after Roux-en-Y gastric bypass. Surg. Endosc. 16:1106 2002).
One limitation, however, has been the removal of pathologic specimens that are larger than the port sites used to perform these surgeries. In abdominal laparoscopy, it is impossible to remove large specimens without cutting or morcellating the specimen within the abdominal cavity or making an incision in the abdominal wall that is large enough to accommodate removal of the large specimen. Recently, surgeons have taken advantage of natural orifices (vagina, rectum, urethra, and gastrointestinal tract) to perform Natural Orifice Transluminal Endoscopic Surgery (NOTES) procedures with good results (Bessler, M.; Gumbs, A. A.; Milone, L.; Evanko, J. C.; Stevens, P.; Fowler, D. Video. Pure natural orifice transluminal endoscopic surgery (NOTES) cholecystectomy. Surg Endosc 24: 2316-2317; 2010; Kaouk, J. H.; White, W. M.; Goel, R. K.; Brethauer, S.; Crouzet, S.; Rackley, R. R.; Moore, C.; Ingber, M. S.; Haber, G. P. NOTES transvaginal nephrectomy: first human experience. Urology 74: 5-8; 2009). NOTES has been used for diagnostic and therapeutic procedures including) organ removal, though current articulating instruments for use with NOTES are disposable, increasing costs compared to standard laparoscopic procedures, and removal of large tumors or solid organs cannot be performed using NOTES (Dapri, Single access laparoscopic surgery: Complementary or alternative to NOTES? World J Gastrointest Surg. 2010 Jun. 27; 2(6): 207-9). Advantages of NOTES include cosmetic results, reduced anesthesia requirements; faster recovery and shorter hospital stays; decreased abdominal trauma and therefore potential complications of transabdominal wound infections, such as hernias, less need for immunosuppression and pain killers; and better postoperative pulmonary and diaphragmantic function.
Another limitation in traditional laparoscopic surgery is the size of the instruments used. A typical umbilicus laparoscopic port incision is no larger than 15 mm, and other support incisions are usually much smaller. Larger incisions lead to more scarring and the potential for hernia formation. Therefore, the tools used for laparoscopy are small in size to fit these incision limitations.
The vagina is the ideal portal to access the abdominal cavity for women undergoing minimally invasive laparoscopic surgery, and is regaining interest in the surgical community (Auyang, E. D.; Santos, B. F.; Enter, D. H.; Hungness, E. S.; Soper, N. J. Natural orifice translumenal endoscopic surgery (NOTES((R))): a technical review. Surg Endosc 25: 3135-3148; 2011; Stark, M.; Benhidjeb, T. Natural Orifice Surgery: Transdouglas surgery—a new concept. JSLS 12: 295-298; 2008) for peritoneal access. According to some computer generated models (Ashton-Miller, J. A.; DeLancey, J. O. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci 1101: 266-296; 2007), its elasticity allows stretching to accommodate dimensions greater than three times its resting state. Accordingly, transvaginal NOTES is considered one of the safest and feasible methods for clinical application. Transvaginal cholecystectomy has been experimentally performed without using laparoscopic assistance.
Ghezzi et al. (Ghezzi, F.; Raio, L.; Mueller, M. D.; Gyr, T.; Buttarelli, M.; Franchi, M. Vaginal extraction of pelvic masses following operative laparoscopy. Surg Endosc 16: 1691-1696; 2002.) and Spuhler et al. (Spuhler, S. C.; Sauthier, P. G.; Chardonnens, E. G.; De Grandi, P. A new vaginal extractor for laparoscopic surgery. J Am Assoc Gynecol Laparosc 1: 401-404; 1994) described devices for the extraction of pelvic masses following laparoscopy. These devices utilized a metal shaft with a fitted rubber ball to provide vaginal occlusion and prevent loss of pneumoperiotoneum. Another device developed in Australia and marketed by Gynetech Pty Ltd, uses a similar hollow tube placed in the vagina (McCartney, A. J. Transvaginal tube as an aid to laparoscopic surgery. Google Patents; 2003). The design of this device is such that the tube fits around the cervix to distinguish the cervicovaginal junction, similar to the Koh colpotomy cup already in use for hysterectomy procedures (Koh, C. H. Simplified total laparoscopic hysterectomy method employing colpotomy incisions. Google Patents; 1996).
However, to date, there are no devices marketed in the U.S. aimed at utilizing the vagina as an access to the peritoneal cavity for the introduction of laparoscopic surgical devices or implants, or the extraction of pathologic specimens. Accordingly, there is a need in the art for devices that permit enhanced access to the abdomen during surgery.